[64]
Infant delivered on january 13, 1992 at 09:53 with initial diagnosis o sepsis and prematurity. Delivery at 34 week gestation with birth weight of 1880 grams. Infant blue, flaccid, and no heart rate upon delivery; staff started immediately bagging by hand with 100% fio-2 indicated on the blender. Hr improved but baby failed to saturate. Bagged for approximately 45 minutes,but bagging failed to bring sats up to 100%. Infant placed on vent and sats shot up to 100%. Fio-2 output from blender suspected; measured at 36% 0-2 with analyzer in nbicu with blender set to 100%. Bioengineering notified of problem and responded immediately. Fio-2 measured in biomed with calibrated oxygen analyzer measured 50. 6% with blender set at 100%. Infant died at 20:00 same daydevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: modification of device. Conclusion: device failure occurred and was related to event, device failure indirectly caused event, device was out of calibration. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5